The OBR Blog

Continuing the tradition of providing you with timely market feedback, OBR and MDoutlook are pleased to share results from MDoutlook’s most recent Quick Poll. This survey was fielded among MDoutlook’s global network of 53,000 cancer physicians to gauge the clinical impact of the recent FDA decision to revoke marketing authorization of bevacizumab (Avastin®) in HER-2 negative metastatic Breast Cancer.

Quick Poll Methodology and Respondents’ Geographic Distribution

On Friday, November 18, 2011, the U.S. Federal Drug Administration (FDA) revoked its regulatory approval concerning the use of bevacizumab (Avastin®) in HER-2 negative metastatic breast cancer

In response to this action, Genentech announced it was moving forward with a new clinical trial including biomarkers to try to identify those most likely to benefit from receiving bevacizumab.

Medicare subsequently announced it would continue covering the cost of bevacizumab for this indication

This Global Quick Poll was launched at 8 a.m. Eastern Time on Saturday, November 19th to gauge the immediate response of the oncology community to this news

Only cancer physicians who treat breast cancer were targeted for this Quick Poll

232 responses were received by Tuesday, November 22nd at 8 a.m. EST

– 59% of responses were from US (39 states)
– 36% of responses from EU
– Overall respondents were from 24 different countries
– No financial compensation was provided to the participants

FDA’s Action Will Severely Limit the Usage of Bevacizumab in the Treatment of HER-2 Negative Metastatic Breast Cancer

Key Conclusions

Overall usage of bevacizumab (BEV) in metastatic breast cancer (mBC) will be cut in half following the FDA’s revocation of its label extension in mBC

– Expected to reduce by 2/3 in US
– Outside of US will still decrease by 1/3

Similar proportional decreases seen in heavy users of bevacizumab (those who use it in >50% of their relevant patients) (data not shown)

Insurance / Payer Coverage of Bevacizumab for Metastatic Breast Cancer Will Have Significant Role in the Decision Making Process

Key Conclusion

Standard payer coverage of bevacizumab in mBC will be a key driver for its future use, especially in the U.S

– Nearly half of US oncologists rate payer coverage as an extremely important decision driver
– One in three oncologists outside the US also see as an extremely important factor

There is a High Amount of Interest in a Biomarker-Driven Trial for Bevacizumab in Metastatic Breast Cancer

Key Conclusion

Nearly 7 out of 8 oncologists are interested & willing to refer patients to the new clinical trial for bevacizumab in HER-2neg mBC.

Geographic location has no impact on the willingness to refer patients to this new clinical trial

Overall Conclusions

The FDA’s actions will have a dramatic impact on the usage of bevacizumab in HER-2 negative metastatic breast cancer

− Usage in the US will decrease by two-thirds
− Usage outside of the US will decrease by one-third

Insurance / Payer coverage will be a key component of the oncologist’s decision process on whether or not to use bevacizumab for breast cancer

− More important in the US than in other locations but still of importance everywhere
− This is of the utmost importance to between 1/3 (Ex-US) and 1/2 (US) of oncologists

Although usage of bevacizumab in practice will be strongly decreased, most oncologists are still interested in the concept of using bevacizumab for metastatic breast cancer and will refer patients to a new clinical trial for it

Final Thoughts

MDoutlook Quick Polls are a fast way of measuring expected acceptance of clinical data post major medical meetings, and perhaps can be used to make some assumptions about adoption amongst providers. In today’s information hungry environment, the speed at which these polls can be conducted and analyzed are advantageous for market planning and “pressure testing” acceptance of data amongst key stakeholders.

Submitted by Robert Stephan, PhD, Sr. Dir. Medical Services and Jan Heybroek, President, The Arcas Group

This blog is a companion piece to an article recently published in our November issue of OBR green titled “Consolidations Come with Concerns as NCI Cooperative Groups Restructure.” Enjoy the blog and then dig a little deeper by reading the OBR green article here.

Prior to the recent consolidations, 10 Cooperative Groups had been sharing that allotment ($150M from the NCI). With roughly 100 phase 3 trials with 20,000 patients and 200 phase 2 trials with 4,000 patients, that works out to only $500K per trial. These Groups are instrumental in establishing standards of cancer patient care and methods for clinical research. Each year they produce over 200 peer-reviewed publications. So, how do the Cooperative Groups accomplish so much with so little?

One answer is that the overall Cooperative Group funding is actually around $360M. Thus, the NCI budget of roughly $150M is less than half of the overall funding. Notably, one-third of the overall funding comes from institutional cost sharing ($88M) and pro bono investigator time ($28M), according to a September 2010 analysis by Judith A. Hautala, PhD, of the Science and Technology Policy Institute (STPI).

Additionally, a quarter of annual cash expenditures come from non-NCI sources, in the form of industry support at $41M (11% of overall Cooperative Group funding), philanthropic support at $6M (1.5%), and other support from sources such as parent institutions and state funds at $9M (2.5%).

The STPI analysis found that the fixed cost to establish and operate a Cooperative Group trial was $1.5M. Infrastructure costs make up 50%-60% of the budget of most of the Groups, with budgets for infrastructure ranging from $15 to $30M. The largest portion of infrastructure costs is statistics and data management (30%-40%), followed by core services (14%-30%). Each phase 3 or phase 2 patient accrual has infrastructure costs of about $3K.

Note that infrastructure costs also include scientific leadership, and the cost of the time commitments of those involved are largely met through $27.5M in pro bono time. This time is either donated by investigators or covered by their home institutions.

Besides infrastructure, patient accrual is the other large piece of Cooperative Group budgets. The estimated real cost of patient accrual is $6K per patient, according to the STPI analysis. While the NCI reimbursement rate has increased from $2K to $5K for phase 2 trials, most phase 3 trials reimburse $2K per patient, though additional funding is available for some complex phase 3 trials. These reimbursement rates do not pay the real cost of patient accrual.

Patients enroll in Cooperative Group trials at cancer centers, academic medical centers, and community oncology practices. Accrual costs are reimbursed at these sites through institutional NIH U10 awards ($5M), Group U10 sub-awards ($12M), per case reimbursements ($52M), and community clinical oncology program accrual reimbursements ($19M). After accounting for these funding mechanisms, over 60% of accrual costs are met through institutional cost sharing ($88M).

Together, pro bono time and institutional cost sharing cover $118M in costs. Consequently, volunteer buy-in is a key component of the success of the Cooperative Groups. Investigator and institutional support account for much of the strength of the Groups. Now the Groups are merging, and concerns have arisen about how this altruistic structure will be affected by these mergers. Meanwhile, their budget from NCI has remained flat.

With all the breakthroughs and advancements oral oncology drugs are offering to patients with cancer, community oncologists recognize there is a crucial link between the acquisition and management of the oral oncologics and the quality of care delivered to their patients. Through collaborative networking and customized assistance, group purchasing organizations, such as RainTree Oncology Services, are offering practices the opportunity to improve the overall revenue model within their pharmacies, enhance practice operational efficiencies, and identify promising new therapeutic strategies. We recently met with Jeff Patton, MD, one of the founders of RainTree Oncology Services, to gain his perspective on the dynamic growth of group purchasing organizations and to find out more about RainTree’s value proposition.

OBR: What are the benefits an oncology practice will have by contracting with RainTree?

JP: Well, we feel that by forging a unified oncology cooperative consisting of the nation’s foremost community oncology practices, that we are creating a dynamic framework for the future. We help practices by providing them with the most advanced therapies to their patients, and we ensure access to the leading insights and up-to-the-minute developments involving community oncology. Historically, patient compliance and adherence to prescriptions have been difficult to monitor. Today, about 35% to 40% of pipeline products are oral with more coming down the pike and only about 40% to 50% of those prescriptions get filled. Our fulfillment rate is over 90% so we offer a huge value proposition for practices.

OBR: How does your strategy work for those who have a retail pharmacy in their practice?

JP: We have three arms. First, we duplicate all the standard GPO services in the oral pharmacy that occur in the infusion suite. By that, I mean, we are building a vast purchasing network that leverages the buying power of premier oncology practices nationwide. As a result, our members can take advantage of improved oral drug acquisition prices in their pharmacies. We are also negotiating typical volume incentive and market share GPO contracts with pharmaceutical manufacturers.

Second, we have pharmacy turnkey services that can broaden a practice’s grasp of oral therapeutic economics and operational efficiencies. So, instead of losing scripts and sizable revenues to specialty pharmacies or drugstore chains, practices can retain these scripts onsite to generate a steady revenue stream. In essence, we help with practice set up, and then we assist in developing a best practices model that is then shared with other practices across the country.

Third, we have a managed care angle. We’re developing a suite of management tools that monitors, tracks, and analyzes complex sets of data related to utilization of oral oncology drugs in the community practice setting. This information can also be shared with other practices around the country and the practices can benchmark.

OBR: What about payers and managed care companies that have a requirement that oral cancer agents be distributed through their wholly owned specialty pharmacy?

JP: Our strategy with specialty pharmacy is to use the “any willing provider” laws in the 23 States that have those laws. In those States, our strategy is to teach physician groups that payers can suggest that the prescription be filled at their specialty pharmacy, but that it is illegal in those States for payers to not allow us to fill it if we meet the criteria that they set forth for a specialty pharmacy. We’re working with consultants to develop a strategy for the States that don’t have any willing provider laws. Once we collect data to show our improved outcomes for patients, it’s going to be hard for the payers to say no.

OBR: There are a lot of oral pipeline products, but many are being studied in niche indications. Can RainTree handle the GPO services for an oral drug that is projected to be low-volume?

JP: Absolutely. If you take 5 or 6 small volume orals, with their price tag per month, there is enough revenue for us to get involved. Even if a few small market drugs are only a “break even” proposition, we will carry and dispense them as a value added service to our patients.

OBR: Your initial focus seems to be on the GPO…

JP: Launch is very critical to the lifecycle of a product. We will have a preferred distributor that distributes the product, and we’ll be the GPO that lays on top of that. Obviously, if a manufacturer wants to do volume incentives or market share contracts, we would administer that contract, but those off-invoice discounts and rebates would go directly to the practice. That’s a big value added to the practice that RainTree can help deliver.

OBR: Please explain the RainTree competitive advantage?

JP: First, if you are one of my patients, do you want to get a call from a call center, or do you want to get a call from one of my nurses or my pharmacist? I don’t think anyone really thinks that nurses from call centers can deliver better care than the pharmacists and nurses located at the point of care in each practices oncology pharmacy. Second, intuitively, who will take better care of these patients: call center nurses with very little clinical information, or my pharmacy techs and pharmacists, who have access to electronic charts and know everything about that patient? Third, we stock drugs. We have them on our shelves so patients don’t have to go through an extended process of authorization and pharmacy visits—which in some cases the pharmacy doesn’t have the drug and it needs to be ordered—that only causes more delay in the patient getting their medication.

We also have adherence and compliance programs to help with prescription fulfillment and we teach practices how to improve their fulfillment rates. Improving capture rate is also one of the big values that we have for practices with a retail pharmacy. When most practices start their pharmacy, prescriptions are still walking out the door because they haven’t changed physicians’ behavior. The best practices we offer allow these practices to keep that revenue in-house and that’s the bottom line.

EDITOR’S NOTE: As many of you may know, AmerisourceBergen Corporation is suing RainTree Oncology Services. Dr. Patton is unable to comment on the litigation at this time.